Description and Brand Names

US Brand Name

Tekamlo

Descriptions

Aliskiren and amlodipine is a combination of medicines that may be used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure will reduce the risk of strokes and heart attacks.

Aliskiren is a renin inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax and this decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen that go to the heart is increased.

Amlodipine is a calcium channel blocker (CCB). It affects the movement of calcium into the cells of the heart and blood vessels. As a result, amlodipine relaxes the blood vessels and increases the supply of blood and oxygen to the heart while reducing its workload.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aliskiren and amlodipine combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren and amlodipine combination in the elderly. However, elderly patients are more likely to have liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

Information about this aliskiren-and-amlodipine-oral-route

Pregnancy Category

Explanation

All Trimesters

D

Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Azilsartan

Benazepril

Candesartan

Captopril

Enalapril

Enalaprilat

Eprosartan

Fosinopril

Irbesartan

Lisinopril

Losartan

Moexipril

Olmesartan

Perindopril

Quinapril

Ramipril

Telmisartan

Trandolapril

Valsartan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amiodarone

Atazanavir

Carbamazepine

Ceritinib

Clarithromycin

Clopidogrel

Conivaptan

Cyclosporine

Dabrafenib

Dantrolene

Domperidone

Droperidol

Eliglustat

Eslicarbazepine Acetate

Fentanyl

Idelalisib

Itraconazole

Lacosamide

Lomitapide

Mitotane

Nilotinib

Piperaquine

Primidone

Siltuximab

Simeprevir

Simvastatin

St John's Wort

Tegafur

Telaprevir

Tocophersolan

Ulipristal

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol

Aceclofenac

Acemetacin

Alprenolol

Amtolmetin Guacil

Aspirin

Atenolol

Avanafil

Betaxolol

Bevantolol

Bisoprolol

Bromfenac

Bucindolol

Bufexamac

Carteolol

Carvedilol

Celecoxib

Celiprolol

Choline Salicylate

Clonixin

Dalfopristin

Dexibuprofen

Dexketoprofen

Diclofenac

Diflunisal

Dilevalol

Diltiazem

Dipyrone

Esmolol

Etodolac

Etofenamate

Etoricoxib

Felbinac

Fenoprofen

Fepradinol

Feprazone

Floctafenine

Fluconazole

Flufenamic Acid

Flurbiprofen

Furosemide

Ibuprofen

Ibuprofen Lysine

Imatinib

Indinavir

Indomethacin

Itraconazole

Ketoconazole

Ketoprofen

Ketorolac

Labetalol

Levobunolol

Lornoxicam

Loxoprofen

Lumiracoxib

Meclofenamate

Mefenamic Acid

Meloxicam

Mepindolol

Metipranolol

Metoprolol

Morniflumate

Nabumetone

Nadolol

Naproxen

Nebivolol

Nepafenac

Niflumic Acid

Nimesulide

Oxaprozin

Oxprenolol

Oxyphenbutazone

Parecoxib

Penbutolol

Phenylbutazone

Piketoprofen

Pindolol

Piroxicam

Pranoprofen

Proglumetacin

Propranolol

Propyphenazone

Proquazone

Quinupristin

Rifampin

Rifapentine

Ritonavir

Rofecoxib

Salicylic Acid

Salsalate

Sodium Salicylate

Sotalol

Sulindac

Talinolol

Tenoxicam

Tertatolol

Tiaprofenic Acid

Timolol

Tolfenamic Acid

Tolmetin

Valdecoxib

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs).

Angioedema, history of—May increase the risk of this condition occurring again.

Congestive heart failure, severe

Heart attack, history—Use may lead to kidney problems.

Diabetes or

Kidney problems—May increase risk of having high potassium in the blood.

Diabetes patients who are also taking certain blood pressure medicines such as angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs)—Should not be used in patients with this condition.

Electrolyte imbalance (e.g., high potassium or low sodium in the body) or

Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. May make these conditions worse.

Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use

This medicine comes with a patient information insert. Read the information carefully and make sure you understand it before taking this medicine. Ask your doctor if you have any questions.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Take this medicine the same way every day. This means take it at the same time and take it consistently with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):

For high blood pressure:

Adults—At first, one tablet containing 150 milligrams (mg) of aliskiren and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg of aliskiren and 10 mg of amlodipine once a day.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the tablets in its original container in a dry place.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, lips, tongue, or throat while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, stop using this medicine until you have talked to your doctor.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

This medicine may worsen the symptoms of angina (chest pain) or cause a heart attack in certain patients with severe heart or blood vessel disease. Check with your doctor right away if you are having chest pain or discomfort, fast or irregular heartbeat, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, shortness of breath, or sweating.

You should not use this medicine (unless your doctor specifically tells you to) if you are also receiving cyclosporine (Gengraf®, Neoral®, Sandimmune®) or itraconazole (Sporanox®).

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet

rapid weight gain

tingling of the hands or feet

unusual weight gain or loss

Rare

Blurred vision

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach

itching skin

lack or loss of strength

muscle cramps

rash

stomach discomfort or upset

Incidence not known

Swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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